NCT07298005RecruitingPhase 2
Sonlicromanol in Post-COVID
SON4PEM Study: Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
The aim of this randomized, double-blind, placebo-controlled, phase II trial, is to study the effect of sonlicromanol on fatigue in patients with post-COVID who experience post-exertional malaise (PEM).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 11 Dec 2025
- Start date
- 3 Apr 2026
- Primary completion date
- Feb 2027
- Lead sponsor
- Michele van Vugt
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT07298005
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 3 Apr 2026 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of the following medication, unless stable for at least one month before study and remaining stable throughout the study: (multi)vitamins, co-enzyme Q10, Vitamin E, riboflavin, amino acids, antioxidant supplements and any medication negatively influencing mitochondrial functioning (including but not limited to valproic acid, glitazones, statins, antivirals, amiodarone and NSAIDs)
Other illness
- Patients at risk for cardiac conduction disorders
- History of clinical significant gastro-intestinal surgery or dysmotility that impairs the adsorption of the IMP
- Clinically significant respiratory or cardiovascular disease
- Unstable neurological disease
- Clinically significant active psychiatric disorder that requires treatment
- History of substance abuse
- Active malignancy within the past 5 years
- History of solid organ transplantation
- Active HIV, hepatitis B or C infection
- Use of the following medication: any moderate or strong Cytochrome P450 (CYP)3A4 inhibitors (all 'conazoles-anti-fungals', HIV antivirals, grapefruit), strong CYP3A4 inducers ((including HIV antivirals, carbamazepine, phenobarbital, phenytoin, rifampicin, St. John's wort, pioglitazone, troglitazone) or any medication metabolized by CYP3A4 with a narrow therapeutic index, medication known to be substrate of Organic Cation Transporter 1 (OCT1) and organic cation transporter 2 (OCT2) or strong P-glycoprotein inhibitors (including amiodarone, azithromycin, captopril, clarithromycin, cyclosporine, piperine, quercetin, quinidine, quinine, reserpine, ritonavir, tariquidar, and verapamil).
Lab values
- Clinically relevant laboratory test value outside the reference range
- Use of any medication known to affect cardiac repolarization unless QTc interval at screening is normal during stable treatment for a period of two weeks, or 5 half-lives
Other
- BMI \< 18.5 or \> 35
- Pregnancy or breastfeeding
Who the study is looking for
- Post COVID according to WHO criteria and verified by post COVID physician
- Post-exertional malaise (PEM) according to DSQ-PEM questionnaire
- Bell's disability score 20-70%
- Mild initial SARS-CoV-2 infection (no hospitalisation)
- WHO performance score of 0 before initial SARS-CoV-2 infection
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam University Medical Center, Location Academic Medical Center (AMC) Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.